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A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04847557
Collaborator
(none)
700
Enrollment
133
Locations
2
Arms
31.1
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be 120 weeks and will depend on duration of study enrollment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Nov 22, 2023
Anticipated Study Completion Date :
Nov 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Placebo administered SC

    Other: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

      Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, 6MWD, and KCCQ CSS will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.

    2. Change from Baseline in Exercise Capacity as Measured by 6MWD [Baseline, Week 52]

    Secondary Outcome Measures

    1. Percent Change from Baseline in Body Weight Loss [Baseline, Week 52]

    2. Change from Baseline in the KCCQ CSS [Baseline, Week 52]

    3. Change from Baseline in 6MWD [Baseline, Week 24]

    4. Percentage of Participants with New York Heart Association (NYHA) Class Change [Week 52]

    5. Time to First Occurrence of HF Events or Cardiovascular (CV) Death [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

    6. Time to First Occurrence of HF Events or All-Cause Death [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

    7. Time to First Occurrence of HF Events [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

    8. Time to Recurrent Events of HF Events and CV Death [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

    9. Time to Recurrent Events of HF Events [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%

    • Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure

    • Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,

    • Stable dose of heart failure medications within 4 weeks of screening

    • Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)

    • 6MWD 100-425m

    • KCCQ CSS ≤80

    Exclusion Criteria:

    • Have had a major cardiovascular event within the last 90 days of screening

    • Have had acute decompensated heart failure within 4 weeks of screening

    • Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions

    • Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease

    • HbA1c ≥9.5% or uncontrolled diabetes

    • History of proliferative diabetic retinopathy or diabetic maculopathy

    • Have a history of pancreatitis

    • eGFR <15 mL/min/1.73 m² or requiring dialysis at screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Center Research Huntsville Alabama United States 35801
    2 Westside Medical Associates of Los Angeles Beverly Hills California United States 90211
    3 Valley Clinical Trials, Inc. Covina California United States 91723
    4 University of California San Diego - La Jolla La Jolla California United States 92037
    5 Amicis Research Center Northridge California United States 91324
    6 Valley Clinical Trials, Inc. Northridge California United States 91325
    7 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    8 South Denver Cardiology Associates, PC Littleton Colorado United States 80120
    9 Cardiology Associates of Fairfield County, P.C. Stamford Connecticut United States 06905
    10 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    11 Clearwater Cardiovascular & Interventional Consultants Clearwater Florida United States 33756
    12 Clearwater Cardiovascular & Interventional Consultants M.D., P.A. Largo Florida United States 33777
    13 Infinite Clinical Research Miami Florida United States 33133
    14 Clearwater Cardiovascular & Interventional Consultants M.D., P.A. Safety Harbor Florida United States 34695
    15 Morehouse School Of Medicine Atlanta Georgia United States 30310
    16 St. Luke's Boise Medical Center Boise Idaho United States 83712
    17 Northwest Heart Clinical Research Arlington Heights Illinois United States 60005
    18 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    19 Midwest Heart & Vascular Specialists Overland Park Kansas United States 66211
    20 Grace Research - Bossier Bossier City Louisiana United States 71111
    21 Grace Research - Shreveport Shreveport Louisiana United States 71105
    22 Maryland Cardiovascular Specialists Baltimore Maryland United States 21229
    23 McLaren Bay Region Bay City Michigan United States 48708
    24 St. Louis Heart and Vascular, P.C. Saint Louis Missouri United States 63136
    25 Palm Research Center Tenaya Las Vegas Nevada United States 89128
    26 Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey United States 08035
    27 Lovelace Medical Center Albuquerque New Mexico United States 87102
    28 Saratoga Cardiology Associates Saratoga Springs New York United States 12866
    29 Stony Brook University Stony Brook New York United States 11794
    30 Aultman Hospital Canton Ohio United States 44710
    31 Hightower Clinical Trial Services Oklahoma City Oklahoma United States 73102
    32 Hillsboro Cardiology Hillsboro Oregon United States 97123
    33 Capital Area Research, LLC Camp Hill Pennsylvania United States 17011
    34 Doylestown Hospital Doylestown Pennsylvania United States 18901
    35 UPMC Clinical Trials Pittsburgh Pennsylvania United States 15213
    36 Medical University of South Carolina Charleston South Carolina United States 29425
    37 The Stern Cardiovascular Foundation Germantown Tennessee United States 38138
    38 DiscoveResearch Beaumont Texas United States 77701
    39 Sherman Clinical Research Sherman Texas United States 75092
    40 Northwest Houston Heart Center Tomball Texas United States 77375
    41 Intermountain Medical Center Murray Utah United States 84107
    42 Pulse Heart Institute Puyallup Washington United States 98372
    43 West Virginia University Morgantown West Virginia United States 26506
    44 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina C1027AAP
    45 DIM Clínica Privada Ramos Mejía Buenos Aires Argentina 1704
    46 Go Centro Medico San Nicolás San Nicolas Buenos Aires Argentina 2900
    47 Fundación Respirar Buenos Aires Buenos Air Argentina 1426
    48 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
    49 CIPREC Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1119ACN
    50 Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1425AGC
    51 Instituto Médico Río Cuarto Río Cuarto Córdoba Argentina 5800
    52 Instituto de Investigaciones Clínicas Rosario - Sanatorio Delta Rosario Santa Fe Argentina 2000
    53 Instituto Médico Especializado (IME) Buenos Aires Argentina 1405
    54 CEMEDIC Buenos Aires Argentina 1407
    55 Instituto de Cardiología "Juana F. Cabral" Corrientes Argentina 3400
    56 Centro de Investigaciones Clinicas Instituto del Corazon (CICIC) Córdoba Argentina X5002HWE
    57 Hospital de Alta Complejidad "Pte. Juan Domingo Perón" Formosa Argentina 3600
    58 Centro Cardiovascular Salta Salta Argentina 4406
    59 Instituto Cardiovascular San Luis San Luis Argentina 5700
    60 Centro de Investigaciones Clinicas del Litoral Santa Fe Argentina 3000
    61 Universidade Federal de Goias Goiania Goiás Brazil 74605-020
    62 Hospital Angelina Caron Campina Grande do Sul Paraná Brazil 83430-000
    63 Centro de Pesquisa Clinica do Coracao Acaraju Sergipe Brazil 49055-530
    64 Loema Instituto de Pesquisa Clinica Campinas São Paulo Brazil 13010-001
    65 Centro de Pesquisa Sao Lucas Campinas São Paulo Brazil 13034-685
    66 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
    67 CAPED Centro Avancado Pesquisa e Diagnostica Ribeirao Preto São Paulo Brazil 14026-020
    68 Pesquisare Saude Santo André São Paulo Brazil 09080-110
    69 Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto São Paulo Brazil 15090000
    70 IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil 22241-180
    71 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    72 Peking University First Hospital Beijing Beijing China 100034
    73 Beijing Friendship Hospital Affiliate of Capital University Beijing Beijing China 100050
    74 Lanzhou university second hospital Lanzhou Gansu China 730030
    75 The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    76 Wuhan University Medical College - Hubei Zhongshan Hospital Wuhan Hubei China 430000
    77 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
    78 The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology Baotou Inner Mongolia China 14010
    79 Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu China 210000
    80 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    81 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    82 Jiangxi Pingxiang People's Hospital Pingxiang Jiangxi China 337055
    83 Jilin Province People's Hospital Changchun Jilin China 130021
    84 China-Japan Union Hospital Changchun Jilin China 130033
    85 The first affiliated hospital of dalian medical university Dalian Shi Liaoning China 116000
    86 The People's Hospital of Liaoning Province Shenyang Liaoning China 110000
    87 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061
    88 Jinan Central Hospital Jinan Shandong China 250013
    89 Zhongshan Hospital,Fudan University Shanghai Shanghai China 200032
    90 Huashan Hospital Affiliated Fudan University Shanghai Shanghai China 200040
    91 West China Hospital of Sichuan University Cheng Du Sichuan China 610041
    92 The First Affiliated Hospital of Xinjiang Medical University Urumchi Xinjiang China 830054
    93 G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi Delhi India 110002
    94 Batra Hospital and Medical Research Centre New Delhi Delhi India 110062
    95 CIMS Hospital - Care Institute of Medical Sciences Ahmedabad Gujarat India 380060
    96 Medanta The Medicity Gurugram Haryana India 122018
    97 Narayana Institute of Cardiac Sciences Bangalore Karnataka India 560099
    98 King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College Mumbai Maharashtra India 400012
    99 Government Medical College And Hospital - Nagpur Nagpur Maharashtra India 440009
    100 Central India Cardiology and Research Institute Nagpur Maharashtra India 440015
    101 AIG Hospitals Hyderabad Telangana India 500032
    102 Barzilai Medical Center Ashkelon HaDarom Israel 7830604
    103 Meir Medical Center Kfar Saba HaMerkaz Israel 4428164
    104 Rabin Medical Center Petah-Tikva HaMerkaz Israel 4941492
    105 Sheba Medical Center Ramat Gan HaMerkaz Israel 5262100
    106 Kaplan Medical Center Rehovot HaMerkaz Israel 7610001
    107 Hillel Yaffe Medical Center Hadera HaTsafon Israel 3810101
    108 Rambam Health Care Campus Haifa HaTsafon Israel 3109601
    109 Galilee Medical Center Nahariya HaTsafon Israel 2210001
    110 Shaare Zedek Medical Center Jerusalem Yerushalayim Israel 9013102
    111 Hadassah Medical Center Jerusalem Yerushalayim Israel 9112001
    112 CIMAB SA de CV Torreón Coahuila Mexico 27000
    113 Virgen Cardiovascular Research SC Guadalajara Jalisco Mexico 44670
    114 Cardiolink Clin Trials Monterrey Nuevo León Mexico 64060
    115 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 64460
    116 Fundación Cardiovascular de Aguascalientes A.C. Aguascalientes Mexico 20230
    117 Hospital Cardiologica Aguescalientes Aguascalientes Mexico 20230
    118 Centro de Estudios Clínicos de Querétaro (CECLIQ) Querétaro Mexico 76000
    119 Clinical Research Center - Universidad Central del Caribe (CRC - UCC) Bayamon Puerto Rico 00956
    120 Research and Cardiovascular Corp. Ponce Puerto Rico 00717
    121 Ivanovo Regional Healthcare Institution Cardiology Dispensary Ivanovo Ivanovskay Russian Federation 153012
    122 Russian Cardiology Research and Production Complex Moscow Moskva Russian Federation 121552
    123 Russian Medical Academy of Postgraduate Education Moscow Moskva Russian Federation 251284
    124 Ryazan Regional Clinical Cardiological Dispensary Ryazan Ryazanskaya Oblast' Russian Federation 390026
    125 Astarta Clinic Saint-Petersburg Sankt-Peterburg Russian Federation 199226
    126 Izhevsk City Clinical Hospital Number 9 Izhevsk Udmurtskaya Respublika Russian Federation 426063
    127 National Taiwan University Hospital Taipei City Taipei Taiwan 100229
    128 Mackay Memorial Hospital-Hsinchu Hsinchu Taiwan 300
    129 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    130 Chung Shan Medical University Hospital Taichung Taiwan 402
    131 Taipei Veterans General Hospital Taipei R. O. C. Taiwan 112
    132 Taipei Medical University Hospital Taipei Taiwan 110
    133 Chang Gung Medical Foundation-Linkou Branch Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04847557
    Other Study ID Numbers:
    • 17757
    • I8F-MC-GPID
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Heart Failure with Preserved Ejection Fraction (HFpEF)
    Additional relevant MeSH terms:
    Heart Failure
    Obesity
    Tirzepatide

    Study Results

    No Results Posted as of Aug 19, 2022